1stOncology™: Cancer Intelligence Service – Page 12630 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Evotec SE to report first-half year 2019 results on 14 August 2019

On August 7, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first half of 2019 on Wednesday, 14 August 2019 (Press release, Evotec, AUG 8, 2019, View Source;announcements/press-releases/p/evotec-se-to-report-first-half-year-2019-results-on-14-august-2019-5841 [SID1234538316]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Wednesday, 14 August 2019

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

From Germany: +49 69 201 744 220

From France: +33 170 709 502

From Italy: +39 02 3600 6663

From the UK: +44 20 3009 2470

From the USA: +1 877 423 0830

Access Code: 37215683#

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialling +49 69 20 17 44 222 (Germany) or +44 20 3364 5150 (UK) and in the USA by dialling +1 844 307 9362. The access code is 315534324#. The on-demand version of the webcast will be available on our website: View Source

Athenex Announces Oral Paclitaxel and Encequidar had a Significantly Higher Response Rate Over IV Paclitaxel in a Phase III Pivotal Study in Metastatic Breast Cancer

On August 7, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported topline data showing that oral paclitaxel and encequidar (Oral Paclitaxel) met the primary efficacy endpoint with statistically significant improvement over IV paclitaxel in a Phase III pivotal study in metastatic breast cancer (Press release, Athenex, AUG 7, 2019, View Source [SID1234573888]).

A total of 402 typical metastatic breast cancer patients were enrolled in a 2 to 1 ratio of Oral Paclitaxel to IV paclitaxel in the ITT population (265 in the Oral Paclitaxel group versus 137 in the IV paclitaxel group). Patient demographics were balanced in the two treatment groups. The primary efficacy endpoint was overall tumor response rate (ORR) confirmed at two consecutive timepoints using RECIST v1.1 criteria. Blinded assessments of tumor response were made by two independent radiologists and an independent adjudicator, using a computer algorithm to assign responses.

Oral Paclitaxel showed a statistically significant improvement compared to IV paclitaxel on the primary efficacy endpoint, with an ORR of 36% for the Oral Paclitaxel group compared to 24% for IV paclitaxel patients based on ITT analysis (p = 0.01). Oral Paclitaxel also showed statistically significant improvement compared to IV paclitaxel based on other analyses on populations excluding non-evaluable patients (which would give higher response rates), with p-values ≤ 0.01 in all analyses. In addition, the results showed that the proportion of confirmed responders with a duration of response of more than 150 days was 2.5 times higher in the Oral Paclitaxel group than in the IV paclitaxel group.

Based on the data cut-off on July 25, 2019, there was a strong trend in progression-free survival (p = 0.077) favoring Oral Paclitaxel over IV paclitaxel, and a strong trend in overall survival (p = 0.11) favoring Oral Paclitaxel over IV paclitaxel. At the cut-off date, a higher proportion of patients on Oral Paclitaxel compared with IV paclitaxel remained progression-free and Athenex expects the PFS and OS trend will continue to improve upon follow-up.

In the study, the Oral Paclitaxel group had lower incidence and severity of neuropathy compared to IV paclitaxel: 57% of IV paclitaxel patients experienced neuropathy (all grades) versus 17% of Oral Paclitaxel patients, with grade 3 neuropathy observed in 8% of IV paclitaxel patients versus 1% of Oral Paclitaxel patients. The results also showed lower incidence of alopecia, arthralgia and myalgia in the Oral Paclitaxel group. The incidence of neutropenia was similar in both groups, but there were more incidents of grade 4 neutropenia and infection in the Oral Paclitaxel group. There were also more gastro-intestinal side effects in the Oral Paclitaxel group.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, "This is the second successful Phase III clinical program accomplished by the clinical team this year. We are excited by the positive results in the Phase III pivotal study, demonstrating improved ORR for Oral Paclitaxel compared to IV paclitaxel across a full spectrum of analyses and lower incidence of neuropathy in the Oral Paclitaxel group. We will be preparing our NDA submission as soon as possible. We are also investigating additional indications for Oral Paclitaxel as well as combinations with other anti-cancer drugs, including biologics and immuno-oncology drugs. With a longer duration of response observed in this trial, we will look into the potential of this drug candidate in metronomic dosing and maintenance therapy. Based on these results, we will aggressively advance the other oral chemotherapy programs."

Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, commented, "Based on the results of the Phase III study, together with the preliminary results generated in the angiosarcoma study, Athenex believes that Oral Paclitaxel has the potential to represent a new class of oral anti-cancer drugs, if approved, based on the findings from this Phase III study showing statistically significant improvement in ORR as monotherapy and longer duration of response over IV paclitaxel, as well as strong trends in improved PFS and OS in patients with metastatic breast cancer. There is also evidence of early onset of activity in angiosarcoma. Adding to this potential are the favorable safety data from this study showing lower incidence of neuropathy, which is currently a major reason for discontinuing IV paclitaxel treatment. There is a potential for Oral Paclitaxel, which is not designed to require steroid pre-medication for immunosuppression, to serve as a cornerstone in chemotherapy in combination with other small molecule anti-cancer drugs, biologics, and immuno-oncology treatment approaches, including other drug candidates in our oncology pipeline."

"We believe the success of the Oral Paclitaxel program serves as a validation for our Orascovery technology platform, which also includes the oral delivery of docetaxel, cabazitaxel, irinotecan, topotecan and eribulin," continued Dr. Lau. "Athenex is transforming from a clinical stage company into a fully integrated company with late-stage oncology product candidates and capabilities across the pharmaceutical value chain, including manufacturing and marketing."

Athenex is also evaluating Oral Paclitaxel in combination with ramucirumab in patients with gastric cancer in an expansion phase of a Phase 1b study, which has shown encouraging preliminary data. Oral Paclitaxel also showed encouraging clinical activity in a pilot study of patients with angiosarcoma. The company is also testing the combination of Oral Paclitaxel with an anti-PD1, pembrolizumab, in patients with advanced solid malignancies.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam rights of Oral Paclitaxel and ZenRx licensed the Australia and New Zealand rights of Oral Paclitaxel from Athenex.

About the Phase III Study of Oral Paclitaxel and Encequidar
The Phase III pivotal study is a randomized, controlled clinical trial designed to compare the the safety and efficacy of Oral Paclitaxel monotherapy against intravenous paclitaxel monotherapy in patients with metastatic breast cancer. The primary endpoint was tumor response rate (confirmed by scans at two consecutive timepoints) as assessed by RECIST v1.1 criteria, a generally accepted method for assessing tumor response. Blinded assessments of tumor response are made by two independent radiologists and an independent adjudicator, using a computer algorithm to assign responses.

Conference Call and Webcast Information
Company management will discuss the Phase III results during its quarterly earnings conference call, today, Wednesday, August 7, 2019, at 8:00am Eastern Time. To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13691069. The live conference call and replay can be accessed via audio webcast at View Source and also on the Investor Relations section of the Company’s website, located at View Source

Inflection Biosciences Announces Publication of Positive Data for PIM/PI3K/mTOR Inhibitor In Neuroblastoma

On August 7th 2019 Inflection Biosciences Ltd, a company developing innovative therapeutics for the treatment of cancer, announced the publication of pre-clinical data showing the company’s PIM/PI3K/mTOR, AUM302 (formerly IBL-302), has promise as a treatment for neuroblastoma (Press release, Inflection Biosciences, AUG 7, 2019, View Source [SID1234538591]). This research has recently been published in the medical journal EMBO Molecular Medicine.

This publication is the result of a collaboration between Inflection Biosciences and two research teams at the Lund University Cancer Centre, Sweden, led by Associate Professors Sofie Mohlin and Daniel Bexell. Inflection Biosciences recently announced that global development and commercialisation rights to AUM302 were granted to AUM Biosciences, Singapore.

Neuroblastoma is an extracranial childhood malignancy of the nervous system that accounts for 15% of all paediatric cancer fatalities. Despite advances in treatment, children with high‐risk disease have poor survival rates, with up to 40% 5‐year mortality. It has previously been shown that targeting the PI3K/mTOR pathway could be a viable treatment for aggressive neuroblastoma. Furthermore, in neuroblastoma cell lines and patient derived xenograft (PDX) derived cell cultures, high levels of PIM were also significantly associated with adverse neuroblastoma patient outcomes.

These published results show that from a panel of 707 cell lines across 47 tumour types, neuroblastoma was the most sensitive tumour type to AUM302 treatment, and out of 16 neuroblastoma cell lines, AUM302 was generally more effective than PI3K inhibitors alone. AUM302 improved the effect of three clinically used chemotherapeutic agents in vitro. AUM302 treatment alone reduced tumour growth in a neuroblastoma xenograft and inhibited neuroblastoma PDX growth in combination with low‐dose cisplatin.

Dr. Bexell, one of the lead authors on the publication, commented: "Adding AUM302 to current treatments to lower administered doses of highly toxic chemotherapy could decrease complications later in life and improve outcomes in these young neuroblastoma patients."

The publication titled ‘Anti‐tumor effects of PIM/PI3K/mTOR triple kinase inhibitor IBL‐302 in neuroblastoma’ can be accessed here.

The research was funded by the Swedish Cancer Society and the Swedish Childhood Cancer Foundation.

Entry into a Material Definitive Agreement

On August 7, 2019, Phio Pharmaceuticals Corp. ("we" or the "Company") reported that it has entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("LPC"), pursuant to which the Company has the right to sell to LPC up to $10,000,000 in shares of the Company’s common stock, $0.0001 par value per share (the "Common Stock"), subject to certain limitations and conditions set forth in the Purchase Agreement (Filing, 8-K, Phio Pharmaceuticals, AUG 7, 2019, View Source [SID1234538542]).

Under the Purchase Agreement, the Company has the right, from time to time at its sole discretion and subject to certain conditions, to direct LPC to purchase up to 200,000 shares of Common Stock on any business day (or $50,000 worth of common stock, whichever is greater) (the "Regular Purchase Amount"). The Company may increase the amount which it directs LPC to purchase, up to a maximum of 500,000 shares of Common Stock, if on the date of the purchase the closing sale price of the Common Stock is not below certain threshold prices, as set forth in the Purchase Agreement, subject in each case to $1,000,000 in total purchase proceeds per purchase date. The purchase price of shares of Common Stock will be based on the market prices of the Common Stock at the time of such purchases. Such sales of Common Stock by the Company, if any, may occur from time to time, at the Company’s option, over the 30-month period commencing on the date that a registration statement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other terms and conditions of the Purchase Agreement are satisfied.

In addition to regular purchases, the Company may also direct LPC to purchase additional amounts as accelerated purchases or as additional purchases if the Company has utilized the Regular Purchase Amount in full and if the closing sale price of the Common Stock exceeds certain threshold prices, as set forth in the Purchase Agreement. In all instances, the Company may not sell shares of its Common Stock to LPC under the Purchase Agreement if it would result in LPC beneficially owning more than 9.99% of the Common Stock.

The Purchase Agreement also limits the Company’s issuance of shares of Common Stock to Lincoln Park thereunder to 5,015,730 shares of Common Stock, representing 19.99% of the shares of Common Stock outstanding on the date of the Purchase Agreement unless (a) stockholder approval is obtained to issue more than such amount or (b) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds the lower of (i) the closing price of our common stock on the Nasdaq Capital Market immediately preceding August 7, 2019 or (ii) the average of the closing price of our common stock on the Nasdaq Capital Market for the five Business Days immediately preceding August 7, 2019.

LPC represented to the Company, among other things, that it was an "accredited investor" (as such term is defined in Rule 501(a)(3) of Regulation D under the Securities Act of 1933, as amended (the "Act")), and the Company sold the securities in reliance upon private placement exemptions from the registration requirements under Section 4(a)(2) of the Act, as well as Rule 506 under Regulation D under the Act. The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions with any third party for a period defined in the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of LPC’s control, LPC does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by LPC, until such event of default is cured.

Actual sales of shares of Common Stock to LPC under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. As a commitment fee for entering into the Purchase Agreement, the Company has agreed to issue to LPC 500,000 shares of Common Stock (the "Commitment Shares"). The Company will not receive any cash proceeds from the issuance of the Commitment Shares.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to LPC. The Company expects that any proceeds received by the Company from such sales to LPC will be used for working capital and general corporate purposes.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

Helix BioPharma Corps. Receives U.S. FDA Approval For Phase Ib/II Pancreatic Trial

On August 7, 2019 Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it has received approval from the U.S. Food and Drug Administration ("FDA"), to initiate a Phase Ib/II study of L-DOS47 and doxorubicin in advanced metastatic pancreatic cancer (Press release, Helix BioPharma, AUG 7, 2019, View Source [SID1234538499]).

This is an open label, non-randomized study designed to evaluate the safety, tolerability and preliminary activity of L-DOS47 in combination with doxorubicin in patients with metastatic pancreatic cancer who have progressed on at least two prior treatment regimens.

Phase Ib will involve a dose escalation safety run-in to determine the appropriate dose to be used in combination with doxorubicin for Phase II. Phase II will evaluate preliminary anti-tumor activity and safety of the Maximum Tolerated Dose of L-DOS47 given in combination with doxorubicin.

"We are very pleased to gain this approval from the FDA," said Dr. Herman Chao, Helix’s Chief Executive Officer. "This represents an expansion of the L-DOS47 application from treating lung cancer to potentially benefiting pancreatic patients. The team is already hard at work to begin all the necessary preparatory activities to move the trial forward. We look forward to be ready to dose patients at the earliest opportunity."